GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
GE Medical Systems is recalling certain Optima XR200/220/240amx mobile radiographic systems after column replacements because functional testing of the safety pawl may not have been performed, which could allow the X-ray arm to drop and injure patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device (potential patient injury from a falling X-ray arm assembly). The source text does not report any known illnesses or injuries; the hazard is theoretical based on the identified safety mechanism failure. Per the rubric, Class II with risk-of-harm but no reported injury supports a score of 3.
Plain-English summary
GE HealthCare is recalling certain Optima XR200/220/240amx mobile digital-ready radiographic systems that have undergone column replacement. In these systems, functional testing of the safety pawl may not have been completed to verify proper assembly.
If the internal counterpoise cable fails, the Column Safety mechanism will not function properly. This could cause the arm carrying the X-ray tube and collimator to drop downward along the column track, potentially resulting in patient injury during an examination.
The recall affects 38 units distributed worldwide, including the United States and Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, and the United Kingdom. Facilities currently using affected systems should contact GE Medical Systems for guidance on remediation and safety measures.
The recalled product
- Product
- Optima XR220amx, Mobile Digital-Ready Radiographic System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- equipment-failure
- mechanical-hazard
- injury-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00840682115261
- System IDs: 05249MOB02.OLD
- 205820DP1
- 228818XR220
- 229276M1
- 240566P1
- 301295OPTIMA2
- 303788SBOPT1
- 314251P5
- 352LEEDP1
- 386FLGDPXR3
- 417347DPORT1
- 512SAMCSB
- 516632OPTIMA2
- 540981ODP7
- 563264OPT
- 601445DP1
- 615338HDP01
- 661949DP2
- 713441OPCDX1
Distribution
Distributed nationwide across the United States.
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